Devices and methods for placement of partitions within a hollow body organ

ABSTRACT

Devices and methods for tissue acquisition and fixation, or gastroplasty, are described. Generally, the devices of the system may be advanced in a minimally invasive manner within a patient&#39;s body, e.g., transorally, endoscopically, percutaneously, etc., to create one or several divisions or plications within the hollow body organ. Such divisions or plications can form restrictive barriers within a organ, or can be placed to form a pouch, or gastric lumen, smaller than the remaining stomach volume to essentially act as the active stomach such as the pouch resulting from a surgical Roux-En-Y gastric bypass procedure. Moreover, the system is configured such that once acquisition of the tissue by the gastroplasty device is accomplished, any manipulation of the acquired tissue is unnecessary as the device is able to automatically configure the acquired tissue into a desired configuration.

FIELD OF THE INVENTION

The present invention relates generally to medical devices and methods.More particularly, it relates to devices and methods for creating apartition within a hollow body organ, particularly a stomach, intestinaltract, or other region of the gastrointestinal tract, and affixing thetissue.

BACKGROUND OF THE INVENTION

In cases of severe obesity, patients may currently undergo several typesof surgery either to tie off or staple portions of the large or smallintestine or stomach, and/or to bypass portions of the same to reducethe amount of food desired by the patient, and the amount absorbed bythe gastrointestinal tract. The procedures currently available includelaparoscopic banding, where a device is used to “tie off” or constrict aportion of the stomach, vertical banded gastroplasty (VBG), or a moreinvasive surgical procedure known as a Roux-En-Y gastric bypass toeffect permanent surgical reduction of the stomach's volume andsubsequent bypass of the intestine.

Typically, these stomach reduction procedures are performed surgicallythrough an open incision and staples or sutures are applied externallyto the stomach or hollow body organ. Such procedures can also beperformed laparoscopically, through the use of smaller incisions, orports, through trocars and other specialized devices. In the case oflaparoscopic banding, an adjustable band is placed around the proximalsection of the stomach reaching from the lesser curve of the stomacharound to the greater curve, thereby creating a constriction or “waist”in a vertical manner between the esophagus and the pylorus. During aVBG, a small pouch (approximately 20 cc in volume) is constructed byforming a vertical partition from the gastroesophageal junction tomidway down the lesser curvature of the stomach by externally applyingstaples, and optionally dividing or resecting a portion of the stomach,followed by creation of a stoma at the outlet of the partition toprevent dilation of the outlet channel and restrict intake. In aRoux-En-Y gastric bypass, the stomach is surgically divided into asmaller upper pouch connected to the esophageal inflow, and a lowerportion, detached from the upper pouch but still connected to theintestinal tract for purposes of secreting digestive juices. A resectedportion of the small intestine is then anastomosed using an end-to-sideanastomosis to the upper pouch, thereby bypassing the majority of theintestine and reducing absorption of caloric intake and causing rapid“dumping” of highly caloric or “junk foods.”

Although the outcome of these stomach reduction surgeries leads topatient weight loss because patients are physically forced to eat lessdue to the reduced size of their stomach, several limitations exist dueto the invasiveness of the procedures, including time, use of generalanesthesia, time and pain associated with the healing of the incisions,and other complications attendant to major surgery. In addition, theseprocedures are only available to a small segment of the obese population(morbid obesity, Body Mass Index≧40) due to their complications, leavingpatients who are considered obese or moderately obese with few, if any,interventional options.

In addition to surgical procedures, certain tools exist for securingtissue such as the stapling devices used in the above-described surgicalprocedures and others such as in the treatment of gastroesophagealreflux disease (GERD). These devices include the GIA® device(Gastrointestinal Anastomosis device manufactured by EthiconEndosurgery, Inc. and a similar product by USSC), and certain clampingand stapling devices as described in U.S. Pat. Nos. 5,403,326;5,571,116; 5,676,674; 5,897,562; 6,494,888; and 6,506,196 for methodsand devices for fundoplication of the stomach to the esophagus for thetreatment of gastroesophageal reflux disease (GERD). In addition,certain tools, such as those described in U.S. Pat. Nos. 5,788,715 and5,947,983, detail an endoscopic suturing device that is inserted throughan endoscope and placed at the site where the esophagus and the stomachmeet. Vacuum is then applied to acquire the adjacent tissue, and aseries of stitches are placed to create a pleat in the sphincter toreduce the backflow of acid from the stomach up through the esophagus.These devices can also be used transorally for the endoscopic treatmentof esophageal varices (dilated blood vessels within the wall of theesophagus).

There is a need for improved devices and procedures. In addition,because of the invasiveness of most of the surgeries used to treatobesity and other gastric disorders such as GERD, and the limitedsuccess of others, there remains a need for improved devices and methodsfor more effective, less invasive hollow organ restriction procedures.

BRIEF SUMMARY OF THE INVENTION

Devices for tissue acquisition and fixation, or gastroplasty, aredescribed that may be utilized for creating a partition within a hollowbody organ, such as the stomach, esophageal junction, and other portionsof the gastrointestinal tract. Generally, the devices of the system maybe advanced in a minimally invasive manner within a patient's body,e.g., transorally, endoscopically, percutaneously, etc., to create oneor several divisions or plications within the hollow body organ. Suchdivisions or plications can form restrictive barriers within the organ,or can be placed to form a pouch, or gastric lumen, smaller than theremaining stomach volume to essentially act as the active stomach suchas the pouch resulting from a surgical Roux-En-Y gastric bypassprocedure. Examples of placing and/or creating divisions or plicationsmay be seen in further detail in U.S. Pat. No. 6,558,400; U.S. patentapplication Ser. No. 10/188,547 filed Jul. 2, 2002; and U.S. patentapplication Ser. No. 10/417,790 filed Apr. 16, 2003, each of which isincorporated herein by reference in its entirety.

The devices may be advanced within a body through a variety of methods,e.g., transorally, transanally, endoscopically, percutaneously, etc., tocreate one or several divisions or plications within a hollow bodyorgan, e.g., to create a gastric lumen or partition to reduce theeffective active area of the stomach (e.g., that which receives theinitial food volume), performed from within the stomach cavity. Thecreation of this smaller gastric lumen may be achieved in a minimallyinvasive procedure completely from within the stomach cavity. Moreover,the devices are configured such that once acquisition of the tissue isaccomplished, manipulation of the acquired tissue is unnecessary as thedevices are able to automatically configure the acquired tissue into adesired configuration.

The devices may generally comprise a first acquisition member and asecond acquisition member in apposition to one another along a firstlongitudinal axis, wherein optionally, at least one of the acquisitionmembers is adapted to adhere tissue thereto such that the tissue ispositioned between the first and second acquisition members, andoptionally wherein at least one of the acquisition members is movablerelative to the first longitudinal axis between a delivery configurationand a deployment configuration. Moreover, the system may also comprise aseptum, or separator, removably positioned between the first and secondacquisition members, wherein at least one of the acquisition members ismovable relative to the septum between a delivery configuration and adeployment configuration.

A handle may be located at a proximal end of an elongate body or memberand used to manipulate the device advanced within the hollow body organas well as control the opening and clamping of the acquisition membersonto the tissue. The elongate body may be comprised of a series oflinks, or of an extrusion fabricated with various lumens to accommodatethe various control mechanisms of the acquisition device. Similarly, thecontrol mechanisms may be grouped together and sheathed in a thin skinsheath, such as a heat shrink. A working lumen may extend entirelythrough the elongate member and may be sized to provide access to thedistal end for various surgical tools, such as an endoscope or othervisualization device, or therapeutic devices such as snares, excisionaltools, biopsy tools, etc. once the distal end of the assembly ispositioned within the hollow body organ. The acquisition members may bejoined to the elongate body via a passive or active hinge member,adaptable to position the assembly. The acquisition members maygenerally comprise a cartridge member placed longitudinally inapposition to an anvil member. The cartridge member may contain one orseveral fasteners, e.g., staples, clips, etc., which may be actuated viacontrols located proximally on the handle assembly. Moreover, the septumor barrier may be removably positioned between the cartridge member andanvil member and used to minimize or eliminate cross acquisition of thetissue into the cartridge member and/or anvil member.

Methods of placing a partition from within a hollow body organ using thedevices disclosed herein generally comprise positioning a firstacquisition member and a second acquisition member adjacent to a regionof tissue within the hollow body organ, wherein the first and secondacquisition members are in apposition to one another along a firstlongitudinal axis, adhering tissue from the region to each of the firstand second acquisition members, and securing the adhered tissue betweenthe first and second acquisition members. Such a method may also involvepivoting at least one of the acquisition members about the longitudinalaxis to an open or closed configuration. Another method may alsocomprise removing a septum from between the first acquisition member andthe second acquisition member.

While the device is in a delivery configuration, i.e., where thecomponents of the distal working portion of the device (the cartridgemember and anvil member) are disposed such that the cartridge and anvilare directly positioned into apposition about the septum. Once desirablypositioned, one or both of the cartridge member and anvil member may berotated about a pivot or translationally moved in parallel to oneanother. Then, portions of the stomach wall may be acquired by, or drawnwithin their respective openings. The configuration of the cartridgemember and anvil member and the positioning of the device within thestomach are such that this tissue acquisition procedure also enables thedevices to be self-adjusting with respect to the acquired tissue.Moreover, the devices are configured such that portions of the stomachwall are automatically positioned for fixation upon being acquired andthe tissue becomes automatically adjusted or tensioned around theperimeter of the distal working portion of the device in the stomach andwithin the distal working portion inner volume, to achieve the desiredresulting geometry (e.g., small gastric pouch or restrictive partitionor baffle). Because of the manner in which the tissue is acquired, thetissue intimately surrounds the cartridge member and anvil member todefine or calibrate the subsequent volume of the resulting gastriclumen. Thus, the gastric volume may be predetermined by adjusting thevolume of the cartridge member and anvil member, or the use of accessorydevices such as a scope or balloon. As a result, once the desired volumeis known and incorporated in the device, the user can achieve acontrolled acquisition and without intraprocedural adjustments orpositioning requirements.

The septum may act effectively as a barrier between the openings tofacilitate the acquisition of the tissue to their respective openingswhile minimizing or eliminating cross acquisition of the tissue into thecartridge member and/or anvil member. In other alternatives, the septummay be omitted from the device and acquisition of the tissue may beaccomplished by sequentially activating vacuum forces within theopenings. Once the tissue has been acquired, the septum may be removedfrom between the cartridge member and anvil member by translating theseptum distally or proximally of the cartridge member and anvil memberor left within the stomach for later removal.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B show side and detailed side views, respectively, of onevariation of an exemplary gastroplasty device described herein.

FIGS. 2A and 2B show perspective detailed views of an exemplarygastroplasty device described herein.

FIGS. 3A and 3B show perspective and end views, respectively, of across-sectioned portion of an exemplary gastroplasty device.

FIGS. 4A and 4B show representative illustrations of how a gastroplastydevice may be advanced transorally through the esophagus of a patientand positioned within the stomach cavity of a stomach.

FIGS. 5A to 5D show end views of an example of how an exemplarygastroplasty device may be used to acquire and fasten tissue within ahollow body organ.

FIG. 5E illustrates a resulting fastened gastric lumen that may beformed using the gastroplasty devices described herein.

FIGS. 5F and 5G demonstrate how a distal working portion of agastroplasty device, and an inner volume, respectively, help to definethe final configuration of the acquired tissue.

FIGS. 5H and 5I show perspective and cross sectional views ofillustrative tissue configurations that may be formed with thegastroplasty devices and methods described herein.

FIGS. 6A and 6B show perspective and end views, respectively, of onevariation of a gastroplasty device, wherein the septum is in position.

FIGS. 7A and 7B show perspective and end views, respectively, of thedevice of FIG. 6A in an open configuration.

FIGS. 8A and 8B show perspective and end views, respectively, of thedevice of FIG. 6A in an open configuration with the septum removed.

FIGS. 9A and 9B show perspective and end views, respectively, of thedevice of FIG. 6A in a closed configuration.

FIGS. 10A to 10C show end views of the cartridge member and anvil memberduring delivery, during tissue acquisition, and prior to clamping of thetissue, respectively, in one example of how a clamping cable may berouted with respect to an optional septum.

FIGS. 11A and 11B show perspective and end views, respectively, ofanother variation of a suitable gastroplasty device.

FIGS. 11C and 11D show perspective views of a gastroplasty device withand without a septum, respectively.

FIGS. 12A to 12C show perspective views of yet another variation of agastroplasty device.

FIGS. 13A and 13B show cross-sectioned perspective and end views,respectively, of alternative acquisition pod assembly.

FIGS. 13C and 13D show cross-sectioned perspective and end views,respectively, of the device of FIGS. 13A and 13B under a high vacuumpressure.

FIGS. 14A to 14D show perspective views of the operation of anothervariation of a gastroplasty device utilizing parallel pod motion.

FIG. 14E shows a cross-sectional perspective view of a portion of thepod members in an open configuration with a septum still in placebetween the cartridge member and anvil member.

FIG. 15 shows a perspective view of yet another variation of agastroplasty device utilizing a translational trolley plate.

FIGS. 16A to 16D show side, end, bottom, and perspective views,respectively, of a variation of a gastroplasty device, which utilizes astatic acquisition pod.

FIG. 16E shows a bottom view of one variation of a gastroplasty devicehaving an arcuate configuration.

FIG. 17 shows a perspective view of a device having an optional featureof projections or serrations which may be defined along the matingsurfaces of the cartridge member and/or anvil member.

FIGS. 18A and 18B show perspective and cross-sectional end views,respectively, of another optional feature of one or more rotatableshafts which may be integrated into the device.

FIGS. 19A and 19B show perspective and detailed perspective views,respectively, of a device having a curved or adjustable segmented staplecartridge.

FIGS. 20A and 20B show perspective views of a septum assembly having atapered edge for facilitating removal of the septum from the hollow bodyorgan.

FIGS. 21A and 21B show perspective views of an alternative septumassembly having ribbed surfaces.

FIG. 21C shows a side view of one example of how collapse of the septummay be facilitated by withdrawing the septum into a receiving member.

FIGS. 22A and 22B show perspective and end views, respectively, of aseptum variation having at least two transverse septum members extendingto opposite sides of the longitudinal septum member.

FIG. 23A illustrates an end view of an extendable septum assemblypositioned between pod members and placed against stomach tissue.

FIGS. 23B and 23C show side views of variations for extending the septumassembly from a low profile delivery to an extended deployedconfiguration.

FIGS. 24A and 24B show end views of an alternative septum assembly whichmay be configured to deploy an extendable septum from a rolled-upconfiguration.

FIGS. 25A and 25B show perspective views of an alternative septumassembly having a collapsible septum member.

FIGS. 25C and 25D show end views of the septum of FIG. 25A in anexpanded or extended configuration and in a collapsed configuration.

FIGS. 26A to 26C show end, bottom, and perspective views, respectively,of yet another alternative septum having radiused corners.

FIGS. 27A and 27B show perspective views of an alternative septumassembly having a low profile delivery configuration where the septummay be comprised of two elongate T-shaped members.

FIGS. 28A to 28C show perspective views of an example of a clampingmechanism having two cam members.

FIG. 29A shows a perspective view of one example of how clamping cablesmay be routed through a gastroplasty device described herein.

FIG. 29B shows a cross-sectioned end view of a parallel clamping devicewith the septum shown.

FIGS. 30A and 30B show side and edge views of an alternativegastroplasty device, utilizing linked pod members.

DETAILED DESCRIPTION OF THE INVENTION

Gastroplasty devices for tissue acquisition and fixation, and methods ofusing them are described. In general, the gastroplasty devices describedherein may be utilized for creating a partition within a hollow bodyorgan, such as the stomach, esophageal junction, and/or other portionsof the gastrointestinal tract. The gastroplasty devices may be advancedwithin a body through a variety of methods, e.g., transorally,transanally, endoscopically, percutaneously, etc., to create one orseveral divisions or plications within the hollow body organ, e.g., tocreate a gastric lumen within the stomach. Further, the gastroplastydevices may be assisted through the use of laparoscopic guidance, inparticular, visualization of the external surface of the hollow bodyorgan to assist in placement of the device, or within the organ cavityto monitor the procedure. Similarly, the devices of the presentinvention may be used in conjunction with other laparoscopic procedures,or may further be modified by an additional step or procedure to enhancethe geometry of the partition. For example, upon placement of apartition of the present invention, it may be desirable to perform asecondary step either transorally, or laparoscopically, to achieve thedesired gastroplasty geometry, such as the placement of a single fold orplication within the gastric lumen or pouch as described in U.S. patentapplication Ser. No. 10/188,547, which was filed Jul. 2, 2002 and isincorporated by reference herein in its entirety, to further restrictthe movement of food through the pouch, or the laparoscopic placement ofa band, clip, ring or other hollow reinforcement member at the outlet ofthe gastric lumen such as is done in a VBG, or lap-band procedure toreinforce or narrow the outlet of the lumen.

The gastroplasty devices described here, allow for the creation of asmaller gastric lumen to be achieved in a minimally invasive surgicalprocedure completely from within the stomach cavity. Moreover, thedevices described herein are configured such that once acquisition ofthe tissue is accomplished, any manipulation of the acquired tissue isunnecessary as the devices are able to automatically configure theacquired tissue into a desired configuration whereby the geometry of thedevices regulates or prescribes the resulting tissue geometry at thetime of acquisition. In operation, the perimeter of the device, and anyopenings therein, form the template or mold cavity around and into whichtissue flows, thereby creating a tissue structure that reflects thegeometry of the mold. That is, as the devices are configured such thatportions of the stomach wall are automatically positioned for fixationupon being acquired, and the tissue becomes automatically adjusted ortensioned around the perimeter of the distal working portion of thedevice in the stomach and within the distal working portion innervolume, to achieve the desired resulting geometry (e.g., small gastricpouch or restrictive partition or baffle). Because of the manner inwhich the tissue is acquired, the tissue intimately surrounds thecartridge member and anvil member to define or calibrate the subsequentvolume of the resulting gastric lumen. Thus, the gastric volume may bepredetermined by adjusting the volume of the cartridge member and anvilmember. As a result, once the desired volume is known and incorporatedin the device, the user can achieve a controlled acquisition and withoutintraprocedural adjustments or positioning requirements. Subsequentmanipulation of the tissue may be performed, if desired, to effectcertain configurations; however, this manipulation may be omittedentirely.

Turning to the figures, FIG. 1A shows a side view of one variation ofgastroplasty assembly 10. Assembly 10 may be generally comprised of anelongate tubular member 12 having handle assembly 16 connected at aproximal end 14. An integrated access assembly 18 may also be connectedat proximal end 14 for providing access to working lumen 22 definedwithin elongate member 12. Elongate member 12 may have a circular orelliptical cross-sectional area. Alternatively, the cross-sectional areamay take on any number of different cross-sectional configurations,e.g., hexagonal, octagonal, etc., provided that it presents anatraumatic surface to the tissue surfaces within the body. In addition,elongate member 12 may be curved, or may comprise a series of links asdescribed in U.S. patent application Ser. No. 10/686,326, which wasfiled on Oct. 14, 2003, and is incorporated by reference in its entiretyherein. In this way, a curved or flexible elongate member, or anelongate member comprising a series of links will help to increase theflexibility of the elongate member, and hence increase the ease in whichthe device is handled and operated. Working lumen 22 may extend entirelythrough tubular member 12 and may be sized to provide access to distalend 20 for various surgical tools or therapies once distal end 20 ofassembly 10 is positioned within a hollow body organ, and in particularmay be useful to place an endoscope or other visualization tool.Alternatively, a fiberscope or other type of visualization tool may beintegrated within the elongate member. Examples of useful scopes may bethe Olympus GIF P140, the Fujinon EG 25PE, and the like. Gastroplastydevice 24 is typically positioned at the distal end of tubular member 12and is also generally configured to be advanced atraumatically throughthe body of a patient and within a hollow body organ, e.g., esophagus,stomach, etc. Alternatively, an optional separate thin walledoversheath, may also be placed over the acquisition device, includingthe elongate member, to assist in placement, or may be placed over aguidewire or obturator down the esophagus prior to placement of thegastroplasty device and removed with the gastroplasty device once theprocedure is complete. The liner may be made of a thin wall polymer suchas polyolefin, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE),silicone and the like, having a wall thickness between 0.004″ and0.025″. This liner can serve to guide the gastroplasty device, as wellas help to limit trauma to the esophagus and other delicate structures.

FIG. 1B shows a closer detail view of the gastroplasty assembly 10. Asshown there, the device comprises a distal working portion, whichcomprises a cartridge member or pod 26 placed longitudinally inapposition to anvil member or pod 28. As described above, when thedevice is in use, the tissue of the stomach wall (including, in someinstances, the muscular tissue layers) are adjusted or tensioned aroundthe perimeter of the distal working portion, and within the distalworking portion inner volume, to achieve a desired resulting geometry(e.g., small gastric pouch or restrictive partition or baffle). Thus,the gastric volume may be predetermined by adjusting the volume of thedistal working portion, inner or outer profile. Cartridge member 26 maycontain one or several fasteners, e.g., staples, clips, etc., which maybe actuated via controls located proximally on handle assembly 16. Aseptum or barrier 32, described in further detail below, may beremovably positioned between cartridge member 26 and anvil member 28while connection member 30 may connect device 24 to tubular member 12.

Handle assembly 16 may be variously configured depending upon thedesired functionality to be implemented on assembly 10. In thisvariation, handle assembly 16 may generally comprise handle 34 for useby the surgeon or physician in advancing, withdrawing, or articulatingassembly 10. A control for articulating the device 24 between an openand closed configuration may be located on handle 34, shown as clampingcontrol knob 36, while a separate control mechanism, shown here asfastener firing lever 38, may be utilized for deploying the fastenerslocated within cartridge member 28. Although specific types of controlsare shown, these are intended only to be illustrative of the types ofcontrol mechanisms which may be utilized and are not intended to belimiting in scope.

Assembly 10 may further have one or several integrated vacuum ports 40proximally located on elongate member 12 for fluid connection to one orseveral vacuum pumps (not shown). One or each of cartridge 26 or anvil28 members may be fluidly connected through a common tube or channel orthrough individually corresponding tubes or channels through elongatemember 12 to vacuum ports 40. Additionally, a scope seal housing 42configured to provide access to the working lumen 22 may also beoptionally provided near or at the proximal end of elongate member 12for the insertion of various tools and devices through elongate member12 for accessing the distal end of the assembly 10. An optionalauxiliary port 44 may also be provided for allowing fluid communicationvia a channel or tubing through elongate member 12 between the proximaland distal ends of the assembly 10. Auxiliary port 44 may be utilizedfor various purposes, e.g., delivery of fluids or gases into the hollowbody organ for transporting drugs or providing insufflation, etc. Asnoted above, the elongate body may be comprised of a series of links,similar to those described in U.S. patent application Ser. No.10/686,326, or of an extrusion fabricated with various lumens toaccommodate the various control wire and mechanisms of the acquisitiondevice. Similarly, the control mechanisms may be grouped together with aflexible band, and then sheathed in a thin skin sheath, such as heatshrink. The elongate member may also be a combination of an extrusionand a thin wall sheath to allow for flexibility, and may utilize braidedmaterials, e.g., stainless steel or superelastic materials such asNickel-Titanium alloy, integrated in the wall of the sheath to preventkinking and enhance torqueability.

A detailed view of one variation of the gastroplasty devices describedherein is shown in the perspective view of FIG. 2A. The cartridge member26 and anvil member 28, as described above, may extend longitudinallyfrom the distal end of elongate member 12 via connection member 30. Thecartridge member 26 and anvil member 28 may be both or singularlyarticulatable relative to one another or relative to elongate member 12.A pivot 50 longitudinally positioned between cartridge member 26 andanvil member 28 may be configured to enable the device to be pivotedinto an open configuration for the acquisition of tissue and a closed ordeployment configuration for delivery or advancement of the device intothe hollow body organ.

If both members 26, 28 are articulatable, they may be configured to beeither simultaneously or sequentially articulatable. The cartridgemember 26 may contain a cartridge 52 container fasteners along an outeredge of the member 26 while the anvil member 28 may have an anvilpositioned along an outer edge of the member 26 such that the anvilcorresponds to the number and position of fasteners within cartridge 52.One or both members 26, 28 may also define openings 56, 58,respectively, along a portion of the length or the entire length of eachof the members 26, 28. One or both of these openings 56, 58 may beconnected via tubing through vacuum lumens 60, 62, respectively, definedthrough elongate member 12 to the vacuum ports 40 located at theproximal end of member 12. Alternatively, a central vacuum lumen maysupply both ports, or may bifurcate at the proximal or distal end ofmember 12. Elongate member 12 may also define various cable lumens 64,66 for the passage of cables for controlling the opening and closing ofmembers 26, 28 as well as additional cable lumen 68 for the passage ofcables for actuating deployment of the fasteners from within cartridge52. Moreover, cable lumen 70 may be used for the passage of cables usedfor controlling the clamping of the members 26, 28 towards one another.

Each of the members 26, 28 may have openings 72, 74 and 76, 78,respectively, defined at the outer corners of each member opposite pivot50 to allow for the routing and passage of clamping cables through thedevice for enabling cartridge member 26 and anvil member 28 to beclamped closed towards one another. FIG. 2B shows a perspective view ofthe acquisition and fixation device of FIG. 2A with the vacuum tubingand cables routed through the device. As shown, vacuum tubing 80, 82 maybe routed through elongate member 12 into a proximal end of one or eachof cartridge member 26 and/or anvil member 28 for fluid connection withrespective openings 56, 58. Cables 84, 86 may be utilized for openingand closing the cartridge member 26 and anvil member 28 and cable 88,which may be routed into cartridge member 26, may be positioned andutilized, e.g., for pulling or pushing a wedge mechanism, to deployfasteners out of cartridge 52. Moreover, clamping cables 90 may bepassed through elongate member 12 and routed through cartridge member 26and anvil member 28 such that cables 92, 94 are passed through openings72, 74 and 76, 78 for clamping cartridge member 26 and anvil member 28closed. Cables 84 and 86 may be replaced by torque shafts connected tohandles at the proximal end of the device, to open and close thecartridge and anvil members.

FIGS. 3A and 3B show perspective and end views, respectively, of across-sectioned portion 100 of a suitable gastroplasty device. As may beseen, septum 32 may be positioned to extend from pivot 50 effectivelyseparating vacuum openings 56, 58 within cartridge member 26 and anvilmember 28, respectively. Adjacent to opening 56 is fastener cartridge 52and adjacent to opening 58 is anvil 54 positioned such that when septum32 is removed or displaced, the articulation of cartridge member 26 andanvil member 28 towards one another about pivot 50 positions cartridge52 in apposition to anvil 54. Alternatively, anvil member 28 cartridgemember 26 may be non-movable or in a fixed position relative to thelongitudinal axis of the device. In this configuration, fastenercartridge 52 and optionally anvil 54, may be actuated to eject fromtheir respective housings to fasten the acquired tissue.

FIGS. 4A and 4B show representative illustrations of how gastroplastydevice 24 may be advanced transorally through the esophagus ES of apatient and positioned within stomach cavity SC of stomach 110. Makingreference now to FIG. 4A, device 24 may be articulated outside thepatient via handle 16 so that the proximal portion of elongate member 12may be positioned such that the spine of the device is placed against aportion of lesser curvature LC and opposite greater curvature GC. Inthis way, the device 24 extends between the gastroesophageal junctionGEJ towards pylorus PY. In addition FIG. 4A depicts the use of aflexible endoscope EN alongside the device 10 to allow directvisualization of the procedure, including the fixation step whereby thescope can then be removed, leaving additional volume remaining in thesmaller gastric pouch that may be helpful when removing or detaching thegastroplasty device 24 from the acquired tissue once it has been fixed.If no direct visualization is required, but additional removal volume isdesired, an optional expandable balloon, or other expandable member EMmay be used alongside the spine of the gastroplasty device, or may beintegrated into the spine of the gastroplasty device using knowntechniques. FIG. 4B shows the positioning of gastroplasty device 10without the aid of an endoscope, or other direct visualizationtechnique.

FIG. 5A shows an end view of device 24 positioned within stomach cavitySC with pivot 50 placed against stomach wall 120, for instance, againstlesser curvature LC in one example of how the device 10 may be used toeffect the creation of a gastric lumen or partition within stomachcavity SC. The device is advanced through the esophagus ES while in adeployment configuration, i.e., where the distal working portion of thedevice DWP is configured so that cartridge member 26 and anvil member 28are closed such that openings 56, 58 and cartridge 52 and anvil 54 aredirectly positioned in apposition about septum 32. When desirablypositioned, one or both of cartridge member 26 and anvil member 28 maybe rotated about pivot 50 in the direction of the arrows shown. FIG. 5Bshows cartridge member 26 and anvil member 28 rotated at an angle with avacuum force activated within openings 56, 58. In certain embodimentswhere no pivoting or movement of the cartridge member 26 or anvil member28 is necessary, the device is advanced in a static state. As seen,portions of the stomach wall 120 may be acquired and drawn withinrespective openings 56, 58. The configuration of cartridge member 26 andanvil member 28 and the positioning of the device 24 within stomachcavity SC are such that this tissue acquisition procedure also enablesthe device 24 to be self-adjusting with respect to the acquired tissue122, 124. More particularly, the device 24 is configured such thatportions of the stomach wall 120 are automatically positioned forfixation upon being acquired and the device 24 becomes automaticallyadjusted within stomach cavity SC relative to the stomach wall 120.Furthermore, because of the manner in which the tissue is acquired, thetissue intimately surrounds the cartridge member 26 and anvil member 28,i.e., the distal working portion of the device DWP, by being tensionedor held around the perimeter PT of the distal working portion of thedevice and within the inner volume IV of the distal working portion ofthe device to define the subsequent volume or resulting geometry RGresulting gastric lumen as shown by the diagonal and hatched linesrespectively in FIGS. 5F and 5G. An illustrative depiction of a crosssection of a resulting tissue geometry is provided in FIG. 5E. Otherdepictions of resulting tissue geometries are provided in FIGS. 5H and5I. Shown there are front views of the distal working portion of thedevice, and cross sectional views (along lines A-A and B-B respectively)of the resulting tissue geometries. In FIG. 5H, the distal workingportion has been configured to provide one plication P, whereas in FIG.5I, the distal working portion has been configured to provide more thanone plication. Multiple plications may be useful, for example, to helpincrease the ease in which the distal working portion of the device isremoved from a patient after tissue has been acquired and fixed. Thus,as these Figs. illustrate, the gastric volume may be predetermined byadjusting the volume of the cartridge member 26 and anvil member 28, orgeometry of the distal working portion of the device, e.g., the distalworking portion of the device may be configured so that the gastrictissue has results in the geometries described, for example, in U.S.patent application Ser. No. 10/417,790, which was filed on Apr. 16, 2003and is hereby incorporated by reference in its entirety.

Optional septum 32 may act effectively as a barrier between openings 56,58 to facilitate the acquisition of the tissue 122, 124 into theirrespective openings 56, 58 while minimizing or eliminating crossacquisition of the tissue into cartridge member 26 and/or anvil member28. In another alternative, septum 32 may be omitted from the device 24and acquisition of the tissue may be accomplished by sequentiallyactivating vacuum forces within openings 56 and 58. That is, thecartridge and anvil members may be orient towards the tissue surface ina sequential fashion, acquiring the tissue adjacent thereto. However,when a septum is employed, it may be removed from between cartridgemember 26 and anvil member 28 by translating the septum 32 distally,laterally, or proximally of cartridge member 26 and anvil member 28,after the tissue has been acquired. Alternatively, the septum may beleft within stomach cavity SC for later removal, or as will be describedin more detail below, may be left within the stomach cavity tobiodegrade. FIG. 5C shows septum 32 having been removed so thatcartridge member 26 and anvil member 28 may be pivoted from the openconfiguration back to its closed configuration in the direction of thearrows shown. Because the septum 32 has been removed, tissue region 126may now be presented for clamping between cartridge 52 and anvil 54.

As shown in FIG. 5D, cartridge member 26 and anvil member 28 may besimply clamped over tissue region 126 and fastened by deploying one orseveral fasteners from within cartridge 52. In acquiring the tissue 122,124, manipulation of the tissue region 126 or the acquired tissue 122,124 may be eliminated entirely due to the automatic positioning of thetissue for fastening. Once the clamped tissue has been fastened, thedevice 24 may be withdrawn entirely from the stomach cavity SC, as shownin FIG. 5E. As seen, one or several fasteners 128, e.g., a line ofstaples, may hold the tissue in its fastened configuration to result inthe creation of a partition, creating a restriction, or when desired,creating a gastric lumen or pouch 130, separate from the remainder ofthe stomach cavity.

Alternative variations of gastroplasty device 24 may also be utilized.For instance, FIG. 6A shows a perspective view of another variation indevice 140 partly cross-sectioned for the sake of clarity. In thisvariation, cartridge member 142 and anvil member 144 may define a curvedor arcuate shape. The septum may also be configured to have alongitudinal barrier portion 146 with a first transverse barrier 152 anda second optional transverse barrier 154. One or both barriers 152, 154may extend in a curved or arcuate shape from the longitudinal septum 146such that an atraumatic surface is presented to tissue duringadvancement within the patient. The septum may be retained betweencartridge member 142 and anvil member 144 via septum detent 148 beingslidably positioned within septum retaining channel 150, which extendslongitudinally between cartridge member 142 and anvil member 144.Longitudinal septum 146 may partition openings 156, 158, which mayfunction in the same manner as described above for adhering tissue. Itmay be advantageous to house a pressure transducer 159 near or withinthe pod(s) or opening(s), to allow the device user to accurately gaugemeasurement of pressure at the site of tissue adhesion. A drop ofpressure within the pod or opening signals to the user that the vacuumseal has been compromised, and therefore the amount of tissue adhered tothe system is not optimal. Readings from the transducer can serve asfeedback to the user that sufficient vacuum pressure has beenmaintained, and therefore be a “go-nogo” trigger to the user. FIG. 6Bshows a cross-sectional end view of the variation 140 from FIG. 6A. Asillustrated, cartridge 162 may retain one or several fasteners 166,shown in this variation as staples, in corresponding apposition to anvil164 when cartridge member 142 and anvil member 144 are in the closed ordelivery configuration. It should be noted that while a rectangularstaple jaw is depicted, it may be desirable to provide a curved track orwedge to facilitate the placement of a curved line of staples, from therectangular jaw. Pivoting member or plate 168, which may function tofacilitate the pivoting the device, may be seen as placed over the outersurface of cartridge member 142 and anvil member 144.

FIG. 7A shows a perspective view of an open configuration 170 of thedevice of FIGS. 6A and 6B for receiving tissue within openings 156, 158.Septum 146 may be removed from the device by translating the septum 146longitudinally in the direction of the arrow. As shown in the end viewin FIG. 7B, pivoting region 160 may be seen expanded via pivoting plate168, which may be made from various biocompatible materials, e.g.,stainless steel, polymers, etc., and which is sufficiently flexible toenable the device to transition between the open and closedconfigurations. FIG. 8A shows the open configuration 180 in which theseptum 146 has been removed from the device. As described above, theseptum may be removed once the tissue has been acquired within theirrespective openings. FIG. 8B shows an end view of the device with theseptum removed. The tissue acquired within open region 182 may beclamped by articulating cartridge member 142 and anvil member 144 in thedirection of the arrows to result in the configuration shown in FIG. 9A,which shows the device 190 ready for fastening the clamped tissue withinclamping region 192. FIG. 9B shows an end view of the device configuredinto its closed configuration for fastening the tissue within clampingregion 192. As described above, because the stomach tissue may beautomatically configured for fastening once the tissue has beenacquired, manipulation of the tissue is rendered unnecessary duringclamping and fastening of the tissue.

In facilitating the clamping of cartridge member 142 and anvil member144 onto the tissue, clamping cables may be utilized, as describedabove. FIGS. 10A to 10C show end views of cartridge member 142 and anvilmember 144 during delivery, during tissue acquisition, and prior toclamping of the tissue, respectively, and one example of how clampingcable 200 may be routed with respect to septum 146. FIG. 10A showsseptum 146 in position between cartridge member 142 and anvil member 144with clamping cable 200 routed within a cable constraining slot 202defined in an adjacent portion of septum 146. The clamping cable 200 mayextend between cartridge member 142 and anvil member 144 throughclamping cable openings 204 defined in both cartridge member 142 andanvil member 144. Once the septum 146 is removed, as shown in FIG. 10C,the clamping cable 200 may be released from slot 202 and tensioned tobring cartridge member 142 and anvil member 144 towards one another, asdescribed in further detail below. Other mechanisms of clamping are alsosuitable, for example, the tissue may be clamped using hydraulic,pneumatic, or electropneumatic mechanisms, all of which are well knownin the art.

FIGS. 11A and 11B shows perspective and end view of another alternativegastroplasty device 210. This variation shows cartridge member 212 andanvil member 214 in a closed configuration with extension member 218connected to longitudinal pivot 216. The septum, in this variation, maycomprise a longitudinal septum member 220 and a perpendicularlypositioned transverse septum member 222, which may extend partially overthe openings 228, 230 when cartridge member 212 and anvil member 214 arein an open configuration, as shown in FIG. 11C. Respective vacuum tubing224, 226 may be fluidly connected to one or both openings 228, 230defined within their respective members 212, 214. FIG. 11D illustratesthe device with the septum translated distally showing a clearer view ofopening 230.

FIGS. 12A to 12C show perspective views of yet another variation ofgastroplasty device 240. In this variation, cartridge member 242 andanvil member 244 may be pivotally connected via longitudinally definedpivot 246. Similar to the variation of FIGS. 11A and 11B, the septum mayalso comprise a longitudinal septum member 248 positionable betweenmembers 242, 244 and an optional perpendicularly configured transverseseptum member 250. Also seen are vacuum tubing 252, 254 fluidly coupledto their respective openings 260, 262. As discussed above, because theresulting gastric lumen may be defined by the shape and volume of thedevice, cartridge member 242 and anvil member 244 may each definetapered distal ends 256, 258, respectively, to provide an atraumaticsurface for advancement within the patient and to facilitate formationof a gastric lumen having a tapered distal region. The proximal shoulderof the members may also be tapered to facilitate removal of the deviceonce the procedure has been completed. Moreover, this variation alsoshows openings 260, 262 which may be elongated to extend over a majorityof the length of their respective members 244, 242.

Yet another variation of an alternative acquisition pod assembly 270 isshown in the cross-sectioned perspective view of FIG. 13A. Thisvariation may generally comprise pod walls 272, 274 each defining anundercut section 276, 278 having projections or serrations 280, 282along their edges directed or angled towards one another. The assembly270 may be comprised of a biocompatible material, e.g., polymers,polycarbonates, etc., which has an elastic bending modulus sufficientlylow to allow for plastic deformation of the pod assembly 270 to occur. Abarrier 286 having a plurality of openings 288 defined over its surfacemay be positioned between pod walls 272, 274 such that tissueacquisition chamber 284 is defined as shown. A vacuum chamber 290 may belocated beneath barrier 286 with vacuum plenum 292 defined by chamber290 and barrier 286.

In operation, as shown in FIG. 13B, tissue 294 may be acquired againstor within acquisition chamber 284 by the application of a relatively lowpressure vacuum force applied through plenum 292, which may create a lowvacuum within chamber 284 through openings 288. Once the tissue 294 hasbeen first acquired, a higher pressure vacuum force may be appliedthrough plenum 292 such that pod walls 272, 274 and undercut sections276, 278, respectively, are plastically deformed and drawn towards oneanother in the direction of the arrows, as shown in FIG. 13C. As theundercut sections 276, 278 are drawn inwards and shown in FIG. 13D, theacquired tissue 294 may become pinched at retained tissue region 296resulting in a temporary mechanical fixation of the tissue. A cessationof the high vacuum force may then result in a relaxation of the podwalls 272, 274 and ultimately of the release of the acquired tissue 294when the vacuum force is ceased altogether. Spearing mechanisms or aplurality of sharp hooks may also be used, in conjunction with, or inlieu of, the undercut sections described above.

Yet another variation of a gastroplasty device 300 is shown in theperspective views of FIGS. 14A to 14D. This particular variation mayutilize a parallel translational motion in moving the cartridge member306 and anvil member 308 between the open and closed configurationrather than a pivoting motion, as described above in other variations.As shown in FIG. 14A, device 300 may comprise pod assembly 302 connectedat the distal end of elongate tubular member 304. Septum 310 may beremovably positioned between cartridge member 306 and anvil member 308.A groove plate 312 defining a longitudinally extending slot may bepositioned adjacent to cartridge member 306 and anvil member 308 on aside opposite to that of septum 310.

FIG. 14B shows cartridge member 306 and anvil member 308 articulatedaway from one another into an open configuration while maintaining aparallel orientation relative to one another. In this openconfiguration, tissue may be acquired and drawn into respective podmembers 302 on opposite sides of septum 310. Groove plate 312, which maybe comprised of various biocompatible materials, e.g., stainless steel,polycarbonate, various polymers, etc., may be held stationary relativeto pod assembly 302 and may further help maintain cartridge member 306and anvil member 308 in their parallel orientation duringreconfiguration. FIG. 14C shows septum 310 removed from betweencartridge member 306 and anvil member 308 by being translated distallyvia septum control member 314, which may be articulated from a proximalend of elongate member 304. Once the septum 310 has been removed,cartridge member 306 and anvil member 308 may be articulated to clamponto the tissue while maintaining their parallel configuration, as shownin FIG. 14D. Once the tissue has been clamped, cartridge member 306 maybe actuated to fasten the tissue. FIG. 14E shows a cross-sectionalperspective view of a portion of pod members 302 in an openconfiguration with septum 310 still in place between cartridge member306 and anvil member 308. As shown, cartridge member 306 and anvilmember 308 along with acquisition chambers 316, 318, respectively, maybe seen maintaining a parallel configuration relative to one another.

FIG. 15 shows a perspective view of yet another variation of agastroplasty device 320 positioned upon the distal end of elongatetubular member 336. Similar to the device of FIG. 14A, cartridge member322 and anvil member 324 may be configured to open and close whilemaintaining a parallel configuration relative to one another. Optionalseptum 326 may also be positionable between members 322, 324. However,device 320 may comprise a translationally movable trolley plate 328which may be advanced or retracted longitudinally. At least two wedgingmembers 330, 332 may protrude from plate 328 at an angle whichcorrespondingly abuts with the distal ends of members 322, 324 such thatwhen plate 328 is longitudinally translated, wedging members 330, 332may drive cartridge member 322 and anvil member 324 towards one anotherin a parallel configuration to clamp onto any tissue which may have beenacquired by device 320. A septum groove 334 may be definedlongitudinally along the plate 328 so as to enable unhindered movementrelative to the septum 326. Cartridge member 322 and anvil member 324may also be configured such that when trolley plate 328 compresses themembers 322, 324 onto tissue, fasteners are automatically deployed intothe tissue to fasten it.

FIGS. 16A to 16C show side, end, and bottom views, respectively, ofanother variation of gastroplasty device 340. Generally, while othervariations have enabled movement of respective pod members, thisvariation may maintain a static acquisition pod. Vacuum pod 342 may becomprised of a variety of biocompatible materials, e.g., polycarbonate,etc., shaped into opposing walls having vacuum plenums 348, 350 definedalong the lengths of the opposing walls. While two vacuum plenums aredepicted, it should be understood that any number of vacuum plenums maybe employed as well. For example, a single vacuum plenum may be used.Similarly, three or more vacuum plenums may be used. A septum having alongitudinal member 346 and an optional perpendicularly positionedtransverse member 344 may be positioned to fit within vacuum pod 342such that at least two tissue acquisition chambers 352, 354 are formedalong the length of pod 342. Alternatively, the septum may only includelongitudinal member 346, and may omit any transverse members entirely,which may aid in reducing the overall profile of the distal working endof the device. The septum may generally be comprised of a similarmaterial as vacuum pod 342 and may be further coated with a layer of alubricious material, such as Teflon®. Furthermore, the septum may beformed of a bioabsorbable material that may either dissolve uponexposure to gastric fluids after tissue has been acquired, or may bereleaseably attached to pods or chambers and fixed in place betweentissue folds (e.g. left behind) once device is removed. The septum mayalso have end member 356 at one end of the septum which may act as astop for the device 340. FIG. 16D shows a perspective view ofacquisition device 340 revealing the vacuum plenum defined along thebottom of pod 342. While rectangular devices are depicted in FIGS.16A-16D, it should be understood that the device 343 can have a curvedor arcuate shape as well, as shown in FIG. 16E. Also depicted there areoptional septum 345 and a single vacuum plenums 347.

To facilitate the acquisition of the tissue, various features may beincorporated into any of the variations described herein. For instance,one optional feature may be seen in FIG. 17, which shows a perspectiveview of gastroplasty device 360 having a plurality of projections orserrations 366, 368 defined along the mating surfaces of cartridgemember 362 and/or anvil member 364. Serrations 366, 368 may bepositioned adjacent to the cartridge and/or anvil to provide additionalmechanical support of the tissue positioned between clamped members ofthe acquisition device 360 during tissue fixation. Alternativelyclearance cuts (not shown) on the cartridge may be included to reducethe surface area and required clamping force for fixation, as well asadding traction to the system. As described above, spearing mechanisms,or sharp projections may be used as well.

Another optional feature which may be integrated with the devices hereinis shown in the perspective view of gastroplasty device 370 of FIG. 18A.A single pod member 372 is shown for illustrative purposes as thefeature of a rotatable shaft may be integrated into any of the devicesdescribed herein. Pod member 372 may define a opening 374 along itslength for receiving tissue therein, as described above; however, thedevice may also comprise at least one rotatable shaft 376 positionedlongitudinally within the pod member 372 adjacent to the opening 374.The rotatable shaft 376 may define one or several projections orserrations 378 along its surface such that tissue drawn into the opening376 via a vacuum force may also be mechanically acquired by rotation ofthe shaft 376 in a first direction to allow serrations 378 to becomeaffixed to the tissue. The shaft 376 may be rotated in a second oppositedirection to release the acquired tissue. Moreover, the pod member 372may acquire the tissue with the vacuum force alone, as described above,with the rotatable shaft 376 alone, or with a combination of both thevacuum force and shaft 376 operated in conjunction with one another.FIG. 18B shows a cross-section of pod member 372 having a secondrotatable shaft 380 also defining projections or serrations 382 alongits surface. In the case of two shafts utilized together, they may beconfigured to be counter-rotating such that the acquired tissue 384 isoptimally retained within opening 374. Likewise, to release the acquiredtissue 384, the shafts 376, 380 may be counter-rotated in the oppositedirection.

Yet another feature which may be integrated with the devices herein isshown in the perspective view of FIG. 19A, which illustrates acquisitionand fixation device 390 having a single pod member for the sake ofclarity. Also shown are septum 400 and opening 402. A segmented staplecartridge 392 having an adjustable curvature and height may beintegrated into any number of the devices described above. Cartridge 392may be comprised of one or more staple cartridge segments 394 which arepivotally connected to one another via joints 396 which may allow notonly pivotal side-to-side motion between segments 394 but also heightadjustments relative to one another.

Each staple cartridge segment 394, as seen in the detail perspectiveview of FIG. 19B, may each define staple openings 398. In connectingwith adjacent cartridge segments 394, a radiused pivot member 404 mayextend from one side of the segment 394 and a receiving cavity 406 maybe defined in the opposite side of the segment 394. Each pivot member404 may extend away from segment 394 such that when positioned into acorresponding receiving cavity 406, adequate spacing exists betweensegments 394 such that side-to-side motion is possible between thesegments 394 to define a curvature of the resulting cartridge 392.Moreover, because of the translational fit between pivot member 404 andcavity 406, the heights of different segments 394 may be varied todefine a curve in the height of cartridge 392, as shown by heightdifferential Z in FIG. 19A and the height differences between adjacentsegments 394 in FIG. 19B. Accordingly, cartridge 392 may be varied inlength by varying the number of segments utilized, as well as varied incurvature and in height. The corresponding anvil member may be adjustedto accordingly match the curvature of the cartridge 392.

In addition to variations on types of pod members and tissue acquisitionenhancements, the septum may also be adjusted in various ways toaccommodate different devices and desired results. For instance,gastroplasty device 410 may be seen in the perspective view of FIG. 20Awith one variation of septum assembly 412 positioned between pod members422, 424. Septum assembly 412 may be seen in better detail in theperspective view of FIG. 20B. In this variation, the septum may have atransverse septum member 414 perpendicularly positioned relative tolongitudinal septum member 416 extending from extension member 420, asdescribed above. However, this variation may define a tapered edge 418along the proximal edge of longitudinal septum member 416. This taperededge 418 may extend at an acute angle from extension member 420 towardstransverse septum member 414 to facilitate removal of the septumassembly 412 from within the hollow body organ.

Another alternative on septum variations is shown in the perspectiveviews of FIGS. 21A and 21B. Ribbed septum assembly 430 may generallycomprise transverse septum member 432, longitudinal septum member 434,tapered edge 440 extending between extension member 438 and transverseseptum member 432. However, the septum members 432, 434 may be ribbed436 to facilitate collapse of the septum assembly 430 when withdrawnfrom the hollow body organ. The hardness and geometry of the septumassembly 430 may be accordingly configured to provide adequate strengthduring vacuum-assisted tissue acquisition yet flexible enough tocollapse when removed from the patient. FIG. 21C shows one example ofhow collapse of the septum may be facilitated by withdrawing the septuminto a receiving member 442 having a tapered opening 444. As the septumassembly 430 is pulled into channel 446, the ribbed surfaces maycollapse into a smaller configuration for withdrawal.

Another alternative septum variation 450 is shown in the perspectiveview of FIG. 22A. Longitudinal septum member 452 may have at least twotransverse septum members 454, 458 extending to opposite sides oflongitudinal septum 452. Each of the transverse septum members 454, 458may define a helical tapered edge 456, 460, respectively, such thatremoval of the septum assembly 450 from the hollow body organ isfacilitated. FIG. 22B shows an end view of the septum assembly 450positioned between pod members 462, 464.

Rather than using a perpendicularly-configured septum, an alternativemay be to utilize a septum member having only a longitudinally extendingmember which extends sufficiently high so as to preventcross-acquisition of tissue into the pod members. FIG. 23A illustratesan end view of an extendable septum assembly 470 positioned between podmembers 472, 474 placed against stomach tissue 476. FIG. 23B shows aside view of one variation for extending the septum assembly 478 from alow profile delivery configuration to an extended deployedconfiguration. Once septum assembly 478 has been advanced into a hollowbody organ in its low profile configuration, the assembly 478 may bedeployed into its expanded configuration. An extension septum member 480may have a number of projections 482, 484 protruding from either side ofextension 480. A corresponding longitudinal septum base 486 may definechannels 488, 490 through which projections 482, 484 located onextension 480, respectively, may be translated within. Moreover,channels 488, 490 may be angled relative to a longitudinal axis definedby septum base 486 such that distally advancing extension 480 relativeto septum base 486 raises extension 480 a distance away from base 486,effectively increasing a height of the septum assembly 478. Projections482, 484 and channels 488, 490 may be covered so that travel of theextension 480 is uninhibited by surrounding tissue.

Similarly, FIG. 23C shows a side view of another septum assemblyvariation 492 in which extension septum member 494 is extendable frombase septum member 496. When advanced distally relative to longitudinalseptum base 496, extension 494 may travserse channels 498, which formramped channel portion 500, defined within base 496 to extend into aseptum assembly 492 having an increased height.

FIG. 24A shows another alternative septum assembly 510 which may beconfigured to deploy an extendable septum from a rolled-upconfiguration. As seen in the end view, septum assembly 510 is in adeployed configuration between pod members 512, 514. Retractable septum520, may be extended from a rolled-up configuration within drum 516,which may be positioned between opposing transverse septum members 518.Cables 522 may extend from transverse septum members 518 for attachmentto pod members 512, 514. After the tissue has been acquired, retractableseptum 520 may be retracted into drum 516 via manipulation of controlcable 524, as seen in FIG. 24B, to assume a low profile for withdrawalfrom the patient.

Another variation of septum assembly 530 is further shown in theperspective views of FIGS. 25A and 25B. Septum assembly 530 may comprisetransverse septum member 532 and collapsible septum member 534, whichmay be configured between a collapsed configuration and an extendedconfiguration. Transverse septum 532 may be elevated and loweredrelative to pod members 548, 550 during delivery and deployment ofseptum assembly 530, e.g., via cross-members 536, 538 which may beconfigured into a scissors-type mechanism. Cross-members 536, 538 mayhave its proximal ends connected to control cable 542, which may berouted through extension member 544, while an intermediate portion ofboth cross-members 536, 538 may be pivotally connected to one anothervia pivot 540. Thus, articulation of control cable 542 from its proximalend by the surgeon or physician may actuate the scissors mechanism toeither raise or lower transverse septum 532 in the directions of thearrow as shown. Transverse septum 532, when positioned between podmembers 548, 550, may be secured via cables 546, as shown in FIG. 25B.

FIGS. 25C and 25D show end views of transverse septum 532 and thecollapsible septum member in an expanded or extended configuration 552and in a collapsed configuration 554. The collapsible septum member maybe enclosed by a biocompatible material to prevent pinching of tissue bythe cross-members 536, 538. Moreover, the material covering thecollapsible septum may also be distensible, if desired. Variousmaterials may be utilized, e.g., nylon, polymeric materials, wovenmaterials made from various polymers, latex, elastomers, etc.

FIGS. 26A to 26C show end, bottom, and perspective views of yet anotheralternative septum 560. This particular septum 560 may be utilized withthe device 340 of FIGS. 16A to 16D. As shown, longitudinal septum 562may be perpendicularly and integrally connected with transverse septummember 564 at one end and base septum member 566 at an opposing end oflongitudinal septum 562. Transverse septum member 564 may defineradiused corners 568 at each of its four corners such that an atraumaticsurface is presented to the tissue during use within a patient.Moreover, septum 560 may be extruded or formed from a singular piece ofbiocompatible material (any of the biocompatible materials suitable forsuch a structure as discussed herein may be utilized) such that auniform structure is created.

FIGS. 27A and 27B show perspective views of an alternative septumassembly 570 which may also be utilized particularly with the device 340as discussed above. FIG. 27A shows septum 570 in a low profile deliveryconfiguration where septum 570 may generally be comprised of twoelongate T-shaped members. Each of the T-shaped members may be furthercomprised of longitudinal septum members 572, 572′ and transverse septummembers 574, 574′, respectively. Each of the two elongate T-shapedmembers need not be uniform with one another depending upon the deviceinto which the septum assembly 570 is placed, but each member may bepivotally connected to one another via pivot 576 at a corner of adjacentlongitudinal members 572, 572′. Thus, during delivery of the device andseptum 570 into the patient body, the low profile configuration of FIG.27A may be maintained and prior to or during tissue acquisition andfixation, one of the members, e.g., septum members 572′, 574′ may bepivoted in the direction of the arrow such that the longitudinalportions of the septum 572, 572′ contact one another to form anacquisition configuration 578 for the septum assembly, as shown in FIG.27B. After tissue acquisition and fixation, the septum may bereconfigured into its low profile configuration for removal from thepatient.

The septum in any of the above embodiments may be formed of abioabsorbable and/or biocompatible material such as polyester (e.g.,DACRON® from E. I. Du Pont de Nemours and Company, Wilmington, Del.),polypropylene, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE),polyether ether ketone (PEEK), nylon, extruded collagen, silicone,polylactic acid (PLA), poly(lactic-co-glycolic acid) (PLGA), orpolyglycolic acid (PGA). Furthermore, it may be flexible, biocompatiblematerial which can either be left behind within the partition orexpelled distally, and either absorbed within the stomach, or digestedand expelled through the patient's gastrointestinal tract.

As discussed above, once the gastroplasty device has acquired theappropriate tissue, the device may be clamped upon the tissue to befastened. Clamping multiple layers of tissue to one another may requirea clamping mechanism which is configured to deliver a high degree ofclamping pressure. One example of such a clamping mechanism 580 is shownin the perspective views of FIGS. 28A to 28C, which show one variationfor opening the clamp. Clamping mechanim 580 may have attachment members582, 584 for secure connection to each of a pod member. Each of theattachment members 582, 584 may be connected to one another viarotatable cams 586, 588, where each cam may have a rotatable pivot, 590,592, respectively, protruding therefrom. FIG. 28A shows clampingmechanism 580 in a closed and clamped configuration while FIG. 28B showsthe mechanism 580 being initially opened. To open (or close) themechanism 580, cam 586 may be rotated by actuating a control cable 600,which may be routed, for instance, through a tubular member 596positioned within the elongate member 12, from its proximal end. Cam 588may then be rotated by actuating control cable 602, which may be routedwithin tubular member 598 also through tubular member 596. Becauseattachment members 582, 584 rotate about pivot 590, a channel 594 may bedefined in member 582 within which pivot 592 may translate when cam 588is rotated to effectuate clamping or opening of the pod members.

In addition to a cam mechanism 580, clamping cables may also beutilized, as discussed above. FIG. 29A shows a perspective view of oneexample of how clamping cables may be routed through an acquisition andfixation device 610. As seen, device 610 having pod members 612, 614 maybe pivotable about longitudinal pivot 616. Although a pivoting device isshown in this variation, the routing of cables may be utilized in any ofthe other acquisition and fixation devices utilizing pivoting motion aswell as parallel clamping. A first clamping cable 620 may be routed intoone of the pod members, e.g., pod member 614, through positioning member630 mounted on pod member 614 and routed over pulley or radiused member622, also contained within pod member 614. First cable 620 may be looped632 adjacent to pivot 616 to allow for placement of the septum (notshown for clarity) and then anchored to clamping cable anchor 618.Likewise, second clamping cable 626 may be routed through positioningmember 630 adjacent to first clamping cable 620 and through pod member614 and over pulley or radiused member 628, also contained within podmember 614. Second cable 626 may also be looped 632 adjacent to pivot616 to allow for placement of the septum and then anchored to clampingcable anchor 624.

FIG. 29B shows a cross-sectioned end view of a parallel clamping devicewith the septum 634 shown. Like features are similarly numbered ascorresponding features from FIG. 29A. As in the pivoting variation,first 620 and second 626 clamping cables may be routed throughcorresponding tubular members 640 and the cables may be looped throughone or more slots 642 defined in septum 634 and subsequently routed intothe opposing pod member for anchoring. Clamping cables 620, 626 arepreferably routed to facilitate the unhindered translation of septum 634as well as to ensure unobstructed access to openings 636, 638 for thetissue to be acquired and fastened.

In yet another clamping variation, FIGS. 30A and 30B show side and edgeviews of an alternative gastroplasty device 650 utilizing linked podmembers. Cartridge member 652 and anvil member 654 may be connected toone another via linking arms 656, 658 pivotally attached to one anothervia pivot 660 at one end of the device 650 and via linking arms 662, 664also pivotally attached to one another via pivot 666 at the opposite endof the device 650. Clamping cables 672 may be routed through tubularmember 670 into the device 650 and over pulleys 674, 676, as describedabove, for moving anvil member 654 between an open and closedconfiguration when acquiring tissue within acquisition region 668.Firing cable 678 may be manipulated to deploy the fasteners from withincartridge member 652 when anvil member 654 is clamped over the acquiredtissue. Deployment of the fasteners from cartridge member 652 may beachieved by incorporation of the firing wedge and other mechanisms astaught in U.S. Pat. No. 4,610,383, which is hereby incorporated byreference in its entirety. In addition, clamping may be accomplished viahydraulic, pneumatic, or electropneumatic mechanisms, as discussedabove.

In describing the system and its components, certain terms have beenused for understanding, brevity, and clarity. They are primarily usedfor descriptive purposes and are intended to be used broadly andconstrued in the same manner. Having now described the invention and itsmethod of use, it should be appreciated that reasonable mechanical andoperational equivalents would be apparent to those skilled in this art.Those variations are considered to be within the equivalence of theclaims appended to the specification.

What is claimed is:
 1. A gastroplasty device, comprising: a cartridgeassembly having a longitudinal axis, the cartridge assembly having afirst tissue acquisition member pivotable about the longitudinal axis inrelation to a second tissue acquisition member, the first tissueacquisition member including a first mating surface that faces a secondmating surface of the second tissue acquisition member when thecartridge assembly is in a closed configuration, each tissue acquisitionmember including a tissue receiving cavity including an opening disposedin the respective first and second mating surfaces, the tissue receivingcavity being coupled to a vacuum source located opposite said opening todraw a first tissue fold into the first acquisition member cavity and asecond tissue fold into the second acquisition member cavity; and astapler disposed on the first tissue acquisition member and the secondtissue acquisition member for stapling the first tissue fold and thesecond tissue fold together; and a septum removably positioned betweenthe first tissue acquisition member and the second tissue acquisitionmember and between the first tissue fold and the second tissue fold. 2.The gastroplasty device of claim 1, wherein the vacuum source of thefirst tissue acquisition member is actuatable separately from the vacuumsource of the second tissue acquisition member.
 3. The gastroplastydevice of claim 1, wherein the cartridge assembly includes an expandableelement selected from the group consisting of a scope, a balloon, and awire form.
 4. The gastroplasty device of claim 1, wherein the septumcomprises a bioabsorbable material.
 5. The gastroplasty device of claim4, wherein the bioabsorbable material is selected from the groupconsisting of polylactic acid (PLA), poly(lactic-co-glycolic acid)(PLGA), and polyglycolic acid (PGA).
 6. The gastroplasty device of claim1, wherein, when the cartridge assembly is in the closed configuration,the first and second mating surfaces face the longitudinal axis of thecartridge assembly.
 7. The gastroplasty device of claim 1, wherein thefirst mating surface is configured to mate with the first tissue foldand the second mating surface is configured to mate with the secondtissue fold.
 8. The gastroplasty device of claim 1, wherein the septumincludes a longitudinal barrier and first and second transverse barrierportions.
 9. The gastroplasty device of claim 8, wherein the first andsecond transverse barrier portions have an arcuate shape and extend fromthe longitudinal barrier.